Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

4STO.FLAT SHELL-36 — Class I MDR by OrtoProfil Prod Romania…

MD Atlas
OrtoProfil Prod Romania SRL

EUDAMED last updated this device on May 22, 2026

4STO.FLAT SHELL-36

5944784ORTMEMBRUINFOCSPKV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OrtoProfil Prod Romania SRL
UDI-DI code: 05944784001523
Reference / catalog number: 4STO.FLAT SHELL-36

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

Organization name: OrtoProfil Prod Romania SRL
SRN: RO-MF-000000526
Manufacturer status: Active

Related devices

4X.388-XL5944784ORTMEMBRUINFOCSPKVOn the market 4T.S-200-PP-285944784ORTMEMBRUINFOCSPKVOn the market 4X.HM-26-05944784ORTPTCVCERVICOTO5NOn the market 4X.HM-26-I5944784ORTPTCVCERVICOTO5NOn the market 4X.HM-26-II5944784ORTPTCVCERVICOTO5NOn the market

Critical warnings

No critical warnings reported for this device.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05944784001523
Basic UDI-DI: 5944784ORTMEMBRUINFOCSPKV
Reference / catalog number: 4STO.FLAT SHELL-36
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Dispozitivul medical asigură în mod optim susţinerea şi corecţia modificărilor statice (picior plat, prăbuşirea boltei plantare longitudinale sau transversale). Se poate utiliza şi în tratarea clavusului sau a pintenului câlcânean, cât şi pentru prevenirea formării “degetului-ciocan” și nu în ultimul rând pentru confort și în susținerea performanțelor sportive. Orteza trebuie utilizată conform indicațiilor de specialitate - FLAT SHELL mărime 36
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Become a partner of MD Atlas

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.